Phase IIa clinical trial, pilot, single centre, prospective, randomized, double-blind, placebo-controlled, with sequential inclusion of patients
20 Patients presenting with a moderate-severe acute ischemic stroke who will be randomized in a 1:1 proportion to intravenous treatment with allogeneic stem cells from adipose tissue or to placebo (vehicle).
- Placebo Drug
ARM 1: Kind: Experimental Label: Placebo Description: In patients randomly assigned to the placebo arm will receive a intravenous solution (containing the vehicle) with the same appearance as the drug under investigation. It will be administered as a single intravenous dose within the first two weeks after the onset of stroke symptoms.
- Allogenic mesenchymal stem cells from adipose tissue Drug
ARM 1: Kind: Experimental Label: Allogeneic stem cells from adipose tissue Description: The experimental drug is a solution of mesenchymal stem cells from adipose tissue. It will be administered as a single intravenous dose within the first two weeks after the onset of stroke symptoms.Dose: 1 million units/kg
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Number of participants with Adverse events, complications.||24 months||Yes|